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Clinical trial

A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.

ID
Name
MBF-RIC-2022
Description
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.
Trial arms
Trial start
2022-06-01
Estimated PCD
2024-06-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
MBF-RIC
Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan
Arms:
MBF-RIC
Other names:
MBF100
Size
61
Primary endpoint
disease-free survival
2 year
Eligibility criteria
Inclusion Criteria: * Age 55-65 * patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors. * patients with AML in remission, or MDS in any stage, or CMML in any stage * inform consent provided Exclusion Criteria: * patients with abnormal liver (\>3N), renal (1.5N) or cardiac function * patients with active infection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ESTIMATED'}}
Updated at
2023-10-24

1 organization

1 product

1 indication

Organization
Shanghai Jiao Tong University School of Medicine
Product
MBF-RIC
Indication
Disease-Free Survival